INION FREEDOMPIN¿

Additional Manufacturer Narrative

ITEM H6 (HEALTH EFFECT - IMPACT CODES) WAS CORRECTED, INION DEVICE WAS NOT REMOVED.

Additional Manufacturer Narrative

THE SITUATION WAS CLASSIFIED BY CUSTOMER AS POST-OPERATIVE WOUND INFECTION, HOWEVER THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE POSSIBLE CAUSES WERE EVALUATED TO POTENTIALLY BE RELATED TO THE LARGE TRAUMA CAUSED BY THE CAR ACCIDENT AND LONG OPERATIVE TIME DURING THE PATIENT'S ORIGINAL OPERATION. BASED ON THE INFORMATION RECEIVED BY INION RELATED TO THE EVENT, IT IS POSSIBLE THAT THE PATIENT'S POOR WOUND HEALING HAS BEEN CAUSED BY LATE-ONSET WOUND INFECTION APPROXIMATELY ONE YEAR POST-OPERATIVELY. LATE-ONSET WOUND INFECTIONS ARE QUITE UNCOMMON, BUT A RECOGNIZED COMPLICATION IN PATIENTS AFTER FRACTURE FIXATION. DESPITE INITIAL WOUND HEALING, THE COMBINATION OF SIGNIFICANT SOFT TISSUE TRAUMA, EXTENDED OPERATIVE TIME, AND IMPLANTED HARDWARE MAY PREDISPOSE TO DELAYED SURGICAL SITE INFECTION. THE PRESENTATION OF INFECTION AFTER THE WOUND HAS ALREADY SEEMED HEALED MAY REFLECT A PREVIOUSLY SUBCLINICAL OR BIOFILM-ASSOCIATED INFECTION THAT BECAME CLINICALLY APPARENT OVER TIME. ALTERNATIVELY, MANIFESTATION OF INFECTION DUE TO ANY MICROORGANISM MAY BE DELAYED BECAUSE POSSIBLE INITIAL ANTIMICROBIAL TREATMENT DID NOT RESULT IN COMPLETE MICROBIAL ERADICATION. BACTERIAL INFECTION IS SURGERY-RELATED RISK, AND THIS RISK ALWAYS EXISTS WHEN SURGERY IS BEING PERFORMED, REGARDLESS WHICH TYPE OF FIXATION IMPLANTS ARE USED. IN CASE OF INFECTION, BIOFILM CAN FORM ON BOTH METALLIC AND BIODEGRADABLE IMPLANTS. THE INION IMPLANTS ARE PROVIDED STERILE AND THE BATCH RECORD REVIEW WHICH WAS CARRIED OUT SHOWED THAT THE STERILIZATION DOSE AND DIMENSIONAL AND MECHANICAL PROPERTIES OF THE BATCH TO WHICH THE IMPLANTS USED IN THE OPERATIONS BELONGED TO WERE WITHIN THE SPECIFICATION. BLISTER AND POUCH SEALS OF THE INSPECTED PACKAGES PASSED THE INSPECTION. THUS, THE POSSIBLE BACTERIA ENTERING THE BODY CAN BE EVALUATED NOT TO BE RELATED TO INION IMPLANT STERILITY. BIOABSORBABLE IMPLANTS CAN SOMETIMES CAUSE INFLAMMATORY TISSUE REACTIONS RELATED TO THE IMPLANT MATERIAL DEGRADATION. TYPICALLY IMPLANT MATERIAL DEGRADATION RELATED INFLAMMATORY TISSUE REACTIONS OCCUR 1-2 YEARS POSTOPERATIVELY. TIME WISE THE PATIENT'S SYMPTOMS COULD ALSO BE RELATED TO IMPLANT MATERIAL DEGRADATION, HOWEVER IT SHOULD BE NOTED THAT IMPLANT MATERIAL DEGRADATION RELATED INFLAMMATORY TISSUE REACTIONS ARE TYPICALLY STERILE FLUID ACCUMULATIONS SEEN WHEN THE BIODEGRADABLE IMPLANTS START TO DEGRADE, THERE IS NO BACTERIAL INVOLVEMENT IN THE DEGRADATION RELATED INFLAMMATORY TISSUE REACTIONS. BUT AS THE TIMING OF THE SYMPTOMS COULD ALSO FIT TO MATERIAL DEGRADATION RELATED TISSUE REACTION AND SINCE INION DOES NOT HAVE BACTERIAL CULTURE RESULTS AND CANNOT BE FULLY AWARE OF THE COURSE OF THE INITIAL WOUND HEALING, GIVEN POSTOPERATIVE TREATMENT AND DIFFERENT ASPECTS RELATED TO THE EMERGENCE OF WOUND INFECTION TYPE SYMPTOMS 1 YEAR POSTOPERATIVELY AFTER INITIAL WOUND HEALING, A FULLY CONCLUSIVE ASSESSMENT WHETHER THE SYMPTOMS EXPERIENCED 1 YEAR AFTER THE IMPLANTATION WERE CAUSED BY LATE ONSET BACTERIAL INFECTION OR IMPLANT MATERIAL DEGRADATION RELATED INFLAMMATORY TISSUE REACTION CANNOT BE MADE WITH FULL CERTAINTY. HOWEVER BECAUSE THE WOUND HAS NOW HEALED WITHOUT THE REMOVAL OF THE INION FREEDOMPIN IMPLANT MATERIAL (ONLY METAL IMPLANTS WERE REMOVED) AND BACTERIA WAS FOUND, AT THE MOMENT THE IMPLANT MATERIAL DEGRADATION RELATED TISSUE REACTION IN THIS CASE DOES NOT SEEM THE MOST LIKELY CAUSE FOR THE SYMPTOMS. INSTEAD LATE ONSET BACTERIAL INFECTION SEEMS MORE LIKELY. METAL IMPLANTS ARE WELL-KNOWN TO HARBOR BIOFILM-FORMING BACTERIA, WHICH CAN REMAIN QUIESCENT FOR LONG PERIODS. THESE BACTERIA CAN BE SHIELDED FROM HOST IMMUNE RESPONSES AND ANTIBIOTICS, AND MAY ONLY BECOME CLINICALLY APPARENT LATER. THE RESOLUTION OF SYMPTOMS FOLLOWING ANTIBIOTIC THERAPY, DEBRIDEMENT, AND REMOVAL OF ONLY THE METAL IMPLANTS SUPPORTS THE CONCLUSION THAT METAL IMPLANTS WERE THE NIDUS OF THE BACTERIA. ADDITIONALLY, CONTINUED HEALING DESPITE THE RETAINED BIOABSORBABLE MATERIALS SUGGESTS THAT THE BIOABSORBABLE IMPLANTS WERE NOT SIGNIFICANTLY CONTRIBUTING TO THE INFECTION PROCESS. TO CONCLUDE, THE MOST PROBABLE CAUSE OF THE LATE-ONSET WOUND INFECTION TYPE SYMPTOMS IS A CHRONIC, BIOFILM-ASSOCIATED INFECTION OF THE METALLIC IMPLANTS, MANIFESTING AFTER A PERIOD OF DORMANCY. CLINICAL RESOLUTION FOLLOWING TARGETED TREATMENT AND SELECTIVE HARDWARE REMOVAL CAN BE CONSIDERED TO SUPPORT THIS ASSESSMENT. HOWEVER THE IMPLANT MATERIAL DEGRADATION RELATED TISSUE REACTION CANNOT BE COMPLETELY RULED OUT WITH THE INFORMATION RECEIVED BY INION, BUT AS MENTIONED, IN THE IMPLANT MATERIAL DEGRADATION RELATED INFLAMMATORY TISSUE REACTIONS THERE IS NO BACTERIAL INVOLVEMENT. ALSO AS THE RESOLUTION OF SYMPTOMS WAS ACHIEVED WITHOUT THE REMOVAL OF BIOABSORBABLE IMPLANTS, IT SUPPORTS THE CONCLUSION THAT THESE MATERIALS DID NOT CONTRIBUTE SIGNIFICANTLY TO THE POOR WOUND HEALING SYMPTOMS EITHER VIA MATERIAL DEGRADATION OR VIA HARBORING BACTERIA IN THE LIKELY LATE-ONSET INFECTION.

Description of Event or Problem

A 56-YEAR-OLD FEMALE WITH HYPERTENSION UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A TIBIA AND FIBULA FRACTURE. BOTH METAL IMPLANTS AND ABSORBABLE INION FREEDOMPINS (INION FREEDOMPIN¿ KIT Ø1.5 MM AND INION FREEDOMPIN¿ KIT Ø2.0 MM (REPORTED SEPARATELY) WERE USED IN THE FIXATION. THE PATIENT WAS DISCHARGED SUCCESSFULLY. APPROXIMATELY 1 YEAR LATER THE PATIENT WAS RE-ADMITTED TO HOSPITAL WITH POOR WOUND HEALING. BASED ON THE INFORMATION RECEIVED, DESPITE INITIAL WOUND HEALING THE WOUND STARTED TO HAVE SYMPTOMS APPROXIMATELY 10 DAYS PRIOR TO THE RE-ADMISSION TO HOSPITAL (1 YEAR AFTER THE ORIGINAL OPERATION), BACTERIAL CULTURES WERE TAKEN AND BACTERIA WAS FOUND. THE PATIENT WAS TREATED WITH ANTIBIOTICS, DEBRIDEMENT AND INTERNAL FIXATION REMOVAL OF METAL IMPLANTS. THE PATIENT WAS DISCHARGED AFTER WOUND HEALING. THE INION FREEDOMPIN IMPLANTS WERE NOT REMOVED AND BASED ON THE INFORMATION RECEIVED BY INION, THE FRACTURES HAVE HEALED.